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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004973-83 |
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This trial discontinued on 2 May 2008 due to lack of enrolment
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifeprunox | Drug | 52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Triglyceride | 8 weeks | |
| Detorioration (composite definition using PANSS total score and CGI-I) | 26 weeks | |
| Change from baseline in Weight, Triglyceride and Cardiovascular risk factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 313 | Anaheim | California | United States | |||
| Site 333 |
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| Quetiapine | Drug | Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day. |
|
| Bifeprunox | Drug | 52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose. |
|
| 52 weeks |
| Anaheim |
| California |
| United States |
| Site 323 | Cerritos | California | United States |
| Site 374 | Costa Mesa | California | United States |
| Site 326 | Culver City | California | United States |
| Site 300 | Glendale | California | United States |
| Site 343 | Long Beach | California | United States |
| Site 356 | Los Angeles | California | United States |
| Site 367 | Los Angeles | California | United States |
| Site 322 | Oceanside | California | United States |
| Site 316 | Pasadena | California | United States |
| Site 302 | Sacramento | California | United States |
| Site 315 | San Diego | California | United States |
| Site 331 | San Diego | California | United States |
| Site 340 | San Diego | California | United States |
| Site 311 | Santa Ana | California | United States |
| Site 336 | Santa Ana | California | United States |
| Site 344 | Torrance | California | United States |
| Site 318 | Denver | Colorado | United States |
| Site 371 | Darien | Connecticut | United States |
| Site 358 | Hartford | Connecticut | United States |
| Site 360 | New Britain | Connecticut | United States |
| Site 317 | Hialeah | Florida | United States |
| Site 362 | Largo | Florida | United States |
| Site 327 | Miami | Florida | United States |
| Site 373 | Miami | Florida | United States |
| Site 334 | North Miami | Florida | United States |
| Site 351 | North Miami | Florida | United States |
| Site 338 | Orange City | Florida | United States |
| Site 332 | Tampa | Florida | United States |
| Site 330 | Atlanta | Georgia | United States |
| Site 308 | Augusta | Georgia | United States |
| Site 370 | Decatur | Georgia | United States |
| Site 366 | Smyma | Georgia | United States |
| Site 337 | Chicago | Illinois | United States |
| Site 361 | Oakbrook Terrace | Illinois | United States |
| Site 335 | Indianapolis | Indiana | United States |
| Site 341 | Lake Charles | Louisiana | United States |
| Site 304 | Shreveport | Louisiana | United States |
| Site 301 | Glen Burnie | Maryland | United States |
| Site 342 | Towson | Maryland | United States |
| Site 328 | Detroit | Michigan | United States |
| Site 357 | Minneapolis | Minnesota | United States |
| Site 309 | St Louis | Missouri | United States |
| Site 369 | Omaha | Nebraska | United States |
| Site 320 | Clementon | New Jersey | United States |
| Site 347 | Clementon | New Jersey | United States |
| Site 310 | Buffalo | New York | United States |
| Site 312 | Buffalo | New York | United States |
| Site 306 | Cedarhurst | New York | United States |
| Site 321 | New York | New York | United States |
| Site 353 | New York | New York | United States |
| Site 372 | New York | New York | United States |
| Site 324 | Staten Island | New York | United States |
| Site 329 | Cincinnati | Ohio | United States |
| Site 345 | Oklahoma City | Oklahoma | United States |
| Site 368 | Oklahoma City | Oklahoma | United States |
| Site 354 | Portland | Oregon | United States |
| Site 314 | Philadelphia | Pennsylvania | United States |
| Site 346 | Philadelphia | Pennsylvania | United States |
| Site 348 | Philadelphia | Pennsylvania | United States |
| Site 350 | Sioux Falls | South Dakota | United States |
| Site 352 | Memphis | Tennessee | United States |
| Site 307 | Austin | Texas | United States |
| Site 303 | Conroe | Texas | United States |
| Site 305 | Houston | Texas | United States |
| Site 325 | San Antonio | Texas | United States |
| Site 319 | Richmond | Virginia | United States |
| Site 349 | Spokane | Washington | United States |
| Site 502 | Buenos Aires | Argentina |
| Site 506 | Buenos Aires | Argentina |
| Site 505 | Córdoba | Argentina |
| Site 507 | Córdoba | Argentina |
| Site 508 | La Plata | Argentina |
| Site 355 | Little Rock | Argentina |
| Site 501 | Mendoza | Argentina |
| Site 504 | Mendoza | Argentina |
| Site 509 | Mendoza | Argentina |
| Site 503 | Rosario | Argentina |
| Site 406 | Kelowna | British Columbia | Canada |
| Site 411 | Victoria | British Columbia | Canada |
| Site 408 | Halifax | Nova Scotia | Canada |
| Site 400 | Burlington | Ontario | Canada |
| Site 401 | Chatham | Ontario | Canada |
| Site 404 | Mississauga | Ontario | Canada |
| Site 407 | Orléans | Ontario | Canada |
| Site 405 | Ottawa | Ontario | Canada |
| Site 409 | Hull | Quebec | Canada |
| Site 403 | Prince Albert | Saskatchewan | Canada |
| Site 410 | Saskatoon | Saskatchewan | Canada |
| Site 413 | Sydney | Canada |
| Site 514 | Coquimbo | Chile |
| Site 510 | Santiago | Chile |
| Site 511 | Santiago | Chile |
| Site 512 | Santiago | Chile |
| Site 513 | Santiago | Chile |
| Site 516 | Santiago | Chile |
| Site 517 | Santiago | Chile |
| Site 518 | Santiago | Chile |
| Site 519 | Santiago | Chile |
| Site 515 | Valdivia | Chile |
| Site 636 | České Budějovice | Czechia |
| Site 637 | Kutná Hora | Czechia |
| Site 604 | Litoměřice | Czechia |
| Site 600 | Olomouc | Czechia |
| Site 601 | Pilsen | Czechia |
| Site 602 | Prague | Czechia |
| Site 605 | Prague | Czechia |
| Site 606 | Tallinn | Estonia |
| Site 608 | Tartu | Estonia |
| Site 607 | Võru | Estonia |
| Site 609 | Helsinki | Finland |
| Site 611 | Helsinki | Finland |
| Site 610 | Turku | Finland |
| Site 612 | Berlin | Germany |
| Site 613 | Berlin | Germany |
| Site 617 | Berlin | Germany |
| Site 620 | Berlin | Germany |
| Site 619 | Bochum-Gerthe | Germany |
| Site 616 | Bonn | Germany |
| Site 615 | München | Germany |
| Site 618 | Siegen | Germany |
| Site 621 | Balassagyarmat | Hungary |
| Site 623 | Budapest | Hungary |
| Site 624 | Győr | Hungary |
| Site 625 | Gyula | Hungary |
| Site 622 | Pécs | Hungary |
| Site 627 | Jelgava | Latvia |
| Site 628 | Kaunas | Latvia |
| Site 626 | Sigulda | Latvia |
| Site 630 | Šilutė | Lithuania |
| Site 629 | Vilnius | Lithuania |
| Site 520 | Lima | Peru |
| Site 521 | Lima | Peru |
| Site 522 | Lima | Peru |
| Site 523 | Lima | Peru |
| Site 524 | Lima | Peru |
| Site 525 | Lima | Peru |
| Site 631 | Bojnice | Slovakia |
| Site 634 | Bratislava | Slovakia |
| Site 632 | Liptovský Mikuláš | Slovakia |
| Site 635 | Michalovce | Slovakia |
| Site 633 | Rimavská Sobota | Slovakia |
| Site 707 | Aucklandpark | South Africa |
| Site 703 | Bellair | South Africa |
| Site 700 | Cape Town | South Africa |
| Site 705 | Cape Town | South Africa |
| Site 706 | Cape Town | South Africa |
| Site 702 | Johannesburg | South Africa |
| Site 701 | Pretoria | South Africa |
| Site 704 | Pretoria | South Africa |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509981 | bifeprunox |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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